Government mandates to serialize pharmaceutical products are increasing around the globe. The Drug Supply Chain Security Act, enacted in November 2013, requires that manufacturers begin serializing all drug products at the saleable unit and case level for the U.S. market starting in November 2017. The EU, China and Brazil have all enacted similar mandates.
There are two predominant drivers behind these serialization mandates: (1) fighting grey market diversion and counterfeiting and (2) aid in government reimbursement programs. Details vary from region to region, but in general all mandates require marking the smallest unit of sale with lot and expiration information, as well as a serial number, creating a unique license plate for each unit. Typically, as suggested in FIG. 1, to facilitate tracking units through the supply chain, units 10 are aggregated into bundles 12, bundles 12 into cases 14 and cases 14 onto pallets 16, with the parent child relationships maintained in a database. “License plate” information for units, bundles, cases and pallets is typically marked on the product in human readable form, as well as being encoded in a 2D code and/or an RFID tag.
The lion's share of the effort required to implement Track & Trace is spent on data management. Tracking the chain of custody of each unit from manufacturing, through distribution, up to the point where it is administered is a monumental task. The data security to ensure that each unit can be authenticated adds to the complexity.
The first critical piece of the chain occurs right on the packaging line. Precise and consistent product handling, marking, inspection and data gathering are required to introduce accurate data into the front end of the system, where individual units (e.g., bottles or other containers) are labeled. In non-RFID systems, variable information printed on each label may include human readable Lot Number, Expiry Date, Serial Number and GTIN along with a 2D code (Label Code) representing the human readable data, along with other information. The GTIN is a code which is used to identify the product. The Serial number combined with the GTIN, uniquely identifies each bottle, throughout the supply chain, all the way to the end user. A label is typically applied to each bottle using a bottle wrap labeler, which wraps the label around the circumference of the product. Once the label is applied to the product, the Label Code can be located anywhere around the circumference of the bottle, making it difficult to scan.
On a typical serialization line, labeled bottles are transported on a conveyor and those bottles need to be identifiable at one or more points along the conveyor. As a bottle moves along the conveyor, it rotates, making it impractical to locate and read the Label Code with a single scanner. An array of scanners, typically four or six, located at angles to the conveyor (Scan Tunnel), can be used to scan images of the label from multiple angles. A sophisticated “stitching” algorithm can be used to piece the images together into a single image, which approximates the flat label. A second algorithm scans the stitched image to locate and read the 2D code.
To eliminate the need for a Scan Tunnel at every point along the line, where the bottle needs to be identified, a separate 2D code (Helper Code) is printed on either the top or the bottom surface of the bottle. The Helper Code is a serial number, assigned to each bottle, to uniquely identify the bottle during the packaging and aggregation process. Because the Helper Code is printed on a nominally flat surface, it can be easily read by a single scanner. The Label Code and the Helper Code need to be associated in a database, allowing access to the unique fixed and variable information printed on the label, by simply scanning the more easily read Helper Code.
In the past, the most commonly used existing technique for associating the Label Code to the Helper Code is to utilize a scan tunnel at a location downstream of the location where the label has been applied to the container. As this downstream station, the containers are passed through a scan tunnel to acquire the Label Code and the Label Code is entered into a FIFO device. A short distance downstream the Helper Code is then scanned and associated with the oldest Label Code in the FIFO device.
It would be desirable to provide a system and method that eliminates the need for a downstream scan tunnel and the associated capital cost, maintenance cost and points of failure.